Medicine
Tirosint SOL 125 mcg/mL oral solution
Tirosint SOL 125 mcg/mL oral solution is a prescription medicine containing Levothyroxine for oral use, marketed by IBSA Pharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Storage as on the product label
Key facts
- Active ingredient (INN)
- Levothyroxine
- Brand
- Tirosint SOL
- Strength
- 125 mcg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 6 pouches
- Marketing authorisation holder
- IBSA Pharma
- Manufacturer
- IBSA Pharma
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H03AA01 Levothyroxine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2019
- Identifiers
- RxCUI 2056462, 2056466, 2056468 +7DailyMed set ID 5d378add-f13d-40f2-99dc-0f2340ab44b7NDC 71858-0140Application NDA206977
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 1 mL in 1 ampule | 71858-0140-5 | IBSA Pharma | 1 March 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 August 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Levothyroxine
Clinical summary
Levothyroxine is a l-thyroxine. It is available as tablets, capsules and powder for injection for oral and intravenous use. MedsAcross supplies Levothyroxine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LevothyroxineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Levothyroxine Sodium prescribing information (Amneal Pharmaceuticals NY) · U.S. National Library of Medicine, DailyMed
Need Tirosint SOL 125 mcg/mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.